Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Non-Alcoholic Fatty Liver Disease: a Randomized Controlled Trial (PARADISE-NAFLD)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This randomized, blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for non-alcoholic fatty liver disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years or older at the time of screening.
• Total liver fat content ≥10% measured by MRI-PDFF.
• Body mass index (BMI) ≥ 25 kg/m\^2.
• The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm.
• Participants should be willing to sign the informed consent form of the study.
Locations
Other Locations
China
JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
The Affiliated Jiangning Hospital of Nanjing Medical University
RECRUITING
Nanjing
Suzhou Municipal Hospital
RECRUITING
Suzhou
Contact Information
Primary
Xiangqing Kong
kongxq@njmu.edu.cn
+8613951610265
Backup
Jing Shi
shijing5499@jsph.org.cn
+8615051872305
Time Frame
Start Date: 2024-02-02
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 80
Treatments
Experimental: intervention group
In intervention group, participants will receive the whole peri-renal fat modification therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting and initiating)
Sham_comparator: sham-control group
In sham control group, participants will receive the sham control therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting), however, without initiating the focused ultrasound equipment.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University
Collaborators: The Affiliated Jiangning Hospital of Nanjing Medical University, Suzhou Municipal Hospital